Efficacy and Safety of Bempedoic Acid in Patients Aged ≥75 Years Stratified by Varying Statin Exposure: Results From Phase 3 Studies of Bempedoic Acid

BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) reduces the risk of major vascular events across all age groups. We analyzed phase 3 studies of bempedoic acid to characterize the safety and efficacy in patients aged ≥75 years with and without a concomitant statin. METHODS: Post hoc analysis of bempedoic acid in high-risk patients with cardiovascular disease by age from phase 3 placebo-controlled, randomized clinical trials: two 52-week primary hyperlipidemia studies with maximal background statin ("max-statins pool"), and 1 cardiovascular outcomes trial ("statin-intolerant pool"). Efficacy (LDL-C, non-high-density lipoprotein cholesterol, total cholesterol, high-sensitivity C-reactive protein) and safety were evaluated. RESULTS: The max-statins pool included 3009 (2010 bempedoic acid, 999 placebo) patients. The statin-intolerant pool included 13 970 patients (6992 bempedoic acid, 6978 placebo). In total 7022 patients were aged 18 to <65 years; 7372 were aged 65 to <75 years; 2585 were aged ≥75 years. Placebo-corrected mean percentage change in LDL-C at week 12 in the max-statin pool with bempedoic acid was -18.4% (95% CI, -21.3 to -15.6) for patients aged 18 to <65 years, -18.6% (95% CI, -21.2 to -16.1) for 65 to <75 years, and -18.3% (95% CI, -22.2 to -14.5) for ≥75 years. In the statin-intolerant pool, LDL-C change was -21.9% (95% CI, -23.1 to -20.7) for patients aged 18 to <65 years, -22.9% (95% CI, -24.0 to -21.8) for 65 to <75 years, and -24.5% (95% CI, -26.2 to -22.7) for ≥75 years. Frequency of adverse events compared with placebo was similar across the ages, but more frequent among patients ≥75 years regardless of background statin. Cardiovascular event reduction was statistically comparable across all ages. CONCLUSIONS: Bempedoic acid was well tolerated in patients aged ≥75 years with efficacy and safety comparable with younger subgroups regardless of background statin usage. Bempedoic acid may be considered a viable strategy for managing hypercholesterolemia in adults, regardless of age.